Ulcerative colitis
Conditions
Interventions
test group:Mesalazine enema, 1g/100ml, rectum administered once daily, 1g, subjects will receive 1g/ 100mL mesalazine enema solution before bed for 7 days
Placebo enema solution,100ml, rectum, two doses, subjects received two placebo enema solutions. The first dose was given on days -14 to -2. The second dose was given on day -1.
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Signed written Informed Consent Document(s) (ICD); 2.18 - 45 years of age. The subjects must be at least 18 years (including the 18th birthday) and no more than 45 years (up to the day before the 46th birthday) when they sign the ICD; 3.Body weight = 50 kg (male) or =45 kg (female) and body mass index (BMI) of 19-24 kg/m² (both inclusive); 4.Healthy according to medical history, physical examination, 12-lead ECG, vital signs, and laboratory profile of blood and urine; 5.Healthy rectal and anal status based on digital rectal examination and stool test; 6.Healthy intestinal track status according to medical history with normal defecation frequency (once daily to three times per week during past 3 months); 7.Capable to retain a placebo enema for at least 30 minutes during Day -14 to -2, with diaper weight increase no more than 20 g; 8.Capable to retain a placebo enema for at least 8 hours on Day -1, with diaper weight increase no more than 20 g; 9.Negative virology/serology for human immunodeficiency virus antibodies (HIV-Ab), hepatitis B surface antigen (HBs-Ag), hepatitis C virus antibodies (HCV-Ab), and treponema pallidum antibodies (TP-Ab) at Screening; 10.Negative urine drug screen and alcohol breath test; 11.Agrees to use a barrier contraception method (e.g. condom) from signing the ICD to 3 days after End-of-trial examination; 12.Non-smoker or light smoker (less than five cigarettes, or equivalent, per day). In the latter case, the subject must abstain from smoking during the residential stay at trial site; 13.For female subjects: a) history of normal menstrual cycles with a mean length of 28-35 days within 6 months prior to Screening, b) history of normal menstruation of 3-7 days within 6 months prior to Screening and, c) end-of-menstruation day is within 7 days prior to Day -1.
Exclusion criteria
Exclusion criteria: 1.Presence or a history of clinically significant diseases of the renal, hepatic, gastrointestinal, cardiovascular, musculoskeletal systems or presence or history of clinically significant psychiatric, immunological, endocrine or metabolic diseases; 2.Cancer within the last 5 years except for adequately managed basal cell carcinoma and squamous cell carcinoma of the skin; 3.Presence or history of severe allergy or anaphylactic reactions, such as hypersensitivity to salicylates; 4.Present pregnancy or breastfeeding; 5.History within the last two years or current abuse of drugs or alcohol (>40 g of alcohol/day equivalent to >1 L of beer/day, 0.5 L of wine/day, or 6 glasses (2 cL) of liquor/day); 6.History of previous gastrointestinal surgery; 7.Present diseases of the ano-rectum, including fistulas, anatomic irregularities, rectal tone compromising the ability to hold the enema; 8.Intake of prescribed medication, over-the-counter (OTC) medication, or herbal medicines, within 2 weeks or 5 half-lives of the drug, whichever is longer, prior to 1st dose of mesalazine. Topical treatments of bacterial or fungal infection are allowed if stopped before first dose of IMP; 9.Participate in any clinical trial within the last 12 weeks preceding Screening or longer if judged by the investigator to possibly influence the outcome of the current study; 10.High daily consumption of caffeine-containing beverages (e.g. more than five cups of coffee or equivalent) within the last 12 weeks preceding Screening with a risk of withdrawal symptoms arising during the study that may confound the safety evaluation; 11.Blood donation or major blood loss (=500 mL) within the last 12 weeks preceding the first day of dosing; 12.Previously recruited in this study and has been treated with at least one IMP; 13.Mental incapacity or language barrier precluding adequate understanding or co-operation; 14.Female subjects whose menstruation likely overlaps the planned Treatment Period (Day 1 to 8); 15.Considered by the investigator to be unsuitable to participate in the study for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Single administration period (after the first administration) : AUCt, Cmax, tmax of mesalazine;Multiple dosing periods (after the 5th dosing) : AUCtau, Cmax, tmax of mesalazine;Multiple dosing periods (after 7th dosing) : AUCtau, Cmax, tmax of mesalazine; | — |
Secondary
| Measure | Time frame |
|---|---|
| Single dose period (after the first dose) : AUC, CL/F, Vz/F, ?z, and t? of mesalazine;Multiple dosing periods (after 5th dosing) : AUC, CL/F, Vz/F, Cavg, ?z, and t? of mesalazine;Multiple dosing periods (after 7th dosing) : AUC, CL/F, Vz/F, Cavg, ?z, and t? of mesalazine;Cumulative excretion of methalazine and n-acetylmethalazine in urine within 24 h after the 7th dose of methalazine (Ae);Urinary excretion of methalazine in the form of methalazine and n-acetylmethalazine within 24 h after the 7th dose of methalazine (Fe);Type, frequency, and intensity of adverse events;Clinically significant changes in vital signs, 12-lead electrocardiogram (ECG), clinical chemistry, hematology, and urinalysis; | — |
Countries
China
Contacts
Public ContactJing Zhang
Huashan Hospital, Fudan University
Outcome results
None listed